Nonin 8500M Handheld Pulse Oximeters Recalled for Incorrect Memory Board
Nonin Medical is recalling 15 units of the 8500M Handheld Pulse Oximeter because some devices may contain an incorrect pulse oximetry board lacking the integrated memory feature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves a missing feature (memory) rather than a safety hazard like electrical shock or inaccurate readings causing immediate harm, fitting the Moderate category for a functional defect without reported injuries.
Plain-English summary
Nonin Medical, Inc. is recalling 15 units of the 8500M Handheld Pulse Oximeter. The recall was initiated because some of the distributed devices may not have the correct pulse oximetry board with the integrated memory feature. The 8500M model is specifically designed to include a memory feature, which distinguishes it from the standard Model 8500.
The affected units were distributed in the United States (Michigan, North Carolina, Ohio, Virginia) and Canada. The recall involves specific lot codes ranging from 502002077 to 502002091. Consumers who possess this device should check their unit against the listed codes and contact Nonin Medical for instructions on how to proceed.
The recalled product
- Product
- 8500M Handheld Pulse Oximeter
- Manufacturer
- Nonin Medical, Inc
- Category
- Medical Device — Pulse Oximeter
- Hazard
Distribution
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